The provision of the baby box was associated with safe sleep practices in a low-resource community: a randomized control trial in Ecuador

Background Sudden Unexpected Infant Deaths (SUID) can occur between 1 month and 1 year of age and are inequitably distributed with a greater burden in populations with numerous health disparities. Modifying the infant sleep environment to promote safe sleep is the most effective risk reduction strategy to reduce SUID. The provision of baby boxes with a mattress and infant supplies has been part of a larger anti-poverty social justice maternity package for decades in Finland. While infant mortality rates have generally improved after the maternity package was introduced, little is known about whether the provision of the baby box increased safe sleep practices. The purpose of the study was to evaluate whether the provision of a Finnish-style baby box reinforced safe infant sleep practice in the home in a low-resource community in Ecuador. Methods In this longitudinal randomized controlled trial all participants received the same safe sleep education in their third trimester of pregnancy (n = 100). This was followed by randomization into two groups; the control received a diaper bag and newborn gifts, and the intervention group received a baby box and the same gifts at each timepoint. Four infant sleep practices (room sharing, bed sharing/co-sleeping, position, and soft items in the sleep environment) were assessed at 1 month and 1 months post-delivery during a home visit where safe sleep education was also reinforced with both groups. Results Those in the baby box group were 2.5 times more likely to report safe sleep practices compared with mothers in the diaper bag group at 1 month (odds ratio [OR] = 2.45 and 95% confidence interval [CI]: 1.03–5.86; χ2 = 4.1, p = .043). The group difference was also present at 6-months post-birth: those in the baby box group were 2.9 times more likely to report safe sleep practices compared with those in the diaper bag group (OR = 2.86 and 95% CI: 1.16–7.05; χ2 = 5.2, p = .022). Conclusions While not all participants used the box regularly, the mothers who received the box were more likely to practice safe sleep at 1 month and 6 months. This suggests the baby box may have served as an important prompt towards safer infant sleep practice. Trial registration (Clinical Trial Registry, per clinicaltrials.gov: not applicable under 42 CFR 11.22(b) as the study Facility Location was not in the United States (took place in Ecuador), does not involve FDA IND or IDE, and does not involve a drug, biological or device product that is manufactured in and exported from the US for study in another country. The University of San Francisco Quito, Research Ethics Committee in Human Beings approved the study, #2017- 127 M. The University of Kentucky Office of Research Integrity also approved the study, IRB # 42965). Supplementary Information The online version contains supplementary material available at 10.1186/s12887-022-03832-y.


Confidential
Who are they?(How are they related to you, not names) __________________________________ Do you smoke?

Yes No
In the last year, have you ever drunk alcohol or used drugs more than you meant to?

Yes No
Have you felt you wanted or needed to cut down on your drinking or drug use in the last year? What is the position that the baby should sleep in?
On belly On side On back Why would you choose this position?
Do you plan to let the baby sleep with loose or heavy blankets, pillows, stuffed animals?

Yes No
If yes, why do you plan to let them sleep with these items?
Sleep Practices-last baby: How often did your last baby sleep in the mother's room overnight?
Always Very often Sometimes Rarely Never How often did your last baby sleep in rooms other than with the mother? Always Very often Sometimes Rarely Never In the room, how often did your last baby sleep in bed with the mother? How often is the baby sleeping with loose or heavy blankets, stuffed animals, or pillows? Observation: If the participant is using the baby box as sleeping surface, please check the baby box for any signs of damage.
Baby box is in excellent condition. There is not damage. Encourage participant to continue using it until baby outgrows it. Review with participant safety precautions. Baby box is in good condition. It has some minor damage that does not affect box structure or inside walls. (i.e: minor peeling or scratch on outside wall). Encourage participant to continue using it until baby outgrows it. Review with participant safety precautions.
There is damage to the box structure or peeling of the inside walls. Ask the participant to stop using the baby box as sleeping surface and discuss with her other options to avoid bed-sharing.
If baby box has minor or major damage, please report here. What happened to the box? There is damage to the box structure or peeling of the inside walls. Ask the participant to stop using the baby box as sleeping surface and discuss with her other options to avoid bed-sharing.
If baby box has minor or major damage, please report here. What happened to the box? __________________________________ 10/01/2020 1:46pm projectredcap.org

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Qualitative: Where and how does your baby sleep?
Qualitative: Why did you choose this? What are some of the things that influenced your decision to put the baby to sleep this way?
Qualitative: What are some barriers to doing some of the things you learned at the HoH clinic? Qualitative: If the mother is promoting safe sleep;What are some things that make it easier for you to do some of the things you learned about sleeping at the HaH clinic?
Was the baby asleep for observation during the visit?

Yes No
The next 4 questions are things you notice during interview (do not fill out for participant to see) In which room was the baby sleeping?
Mother's Room Other Room Observation: What surface is the mother putting the baby to sleep?